Photobiomodulation on Molar Verticalization With Mini-implant

NCT04036539 | Completed

• 1 other identifier: verticalization
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study will be to evaluate the effect of photobiomodulation on the acceleration of the orthodontic movement of molar verticalization and its effect on pain and inflammation of the periodontal tissues. Thirty-four healthy patients aged 30-60 years, who need to recover the prosthetic space for oral rehabilitation after loss of the posterior inferior dental elements and inclination of the adjacent element, will be randomly divided into 2 groups: G1 (control group) - verticalization by mini-implant + PBM (photobiomodulation) simulation (placebo); G2 (experimental group) - verticalization by mini-implant + PBM. The movements will occur with the aid of mini-implants and elastomeric chains ligatures. The PBM will occur with diode laser application, 660 nm (nanometers), 100mW (milliwatts), receiving 1J(joule) per point, 10s (seconds), 10 points (5 per buccal and 5 per lingual) and radiant exposure of 25 J / cm². The crevicular gingival fluid (FGC) will be collected to analyzed Interleukins IL1β, IL-6, IL-8, IL-10(Interleukins) and TNF-α (tumor necrosis factor) by ELISA (enzyme-linked immunosorbent assay). Radiographic shots will be taken each month to ascertain the amount (in degrees) of verticalization. To evaluate the pain, the Visual Analogue Scale will be used in all the consultations, and to evaluate the quality of life, the OHIP-14 (oral health impact profile) questionnaire will be applied. Analgesics will be given and the number of drugs will be counted. If the data are normal, they will be submitted to the Student's t-test. The data will be presented as means ± SD(standard deviation) and the value of p will be defined as \<0.05.

Conditions

Orthodontic Appliances; Low-Level Light Therapy

Keywords

orthodontic treatment,; photobiomodulation,; mini-implant,; verticalization of molars

Outcome Measures

Primary Outcomes (1)

• Radiographic measurements

  Radiographic measurements to assess movement rate through tooth angulation versus time at baseline, 30, 60 and 90 days after treatment, Movement rate - With the aid of a ruler (Morelli, Sorocaba, SP, Brazil) and a protractor (transparent Waleu 10290001®), radiographic measurements will be taken at baseline, 30, 60 and 90 days to ascertain the amount (in degrees) of verticalization, using as reference the line of the occlusal plane and the long axis of the inclined tooth (García, 2017). These measurements will be recorded in degrees in each patient's chart for further analysis.

  through study completion on average of one year

Secondary Outcomes (3)

• Pain during movement: Visual Analog Scale (VAS)

  through study completion on average of one year

• Assess the amount of painkillers ingested

  through study completion on average of one year

• Oral health-related quality of life (HRQoL): OHIP-14

  through study completion on average of one year

Study Arms (2)

Control (placebo)

PLACEBO COMPARATOR

Patients in Control will receive the photobiomodulation placebo,application, but with the laser off. Procedures will be performed immediately after the application of forces (placement of elastic bandages) on the tooth, as described: Simulations will be performed with the same laser.This will require 10 seconds of application simulation per point. As 10 points will be simulated, it will take 100 seconds for this simulation.5 points lingual and 5 points at vestibular

Procedure: Placement of the mini-implant and verticalization

Experimental:

EXPERIMENTAL

Experimental: Molar verticalization + PBM (n = 17 + 3) - patients will receive laser treatment (photobiomodulation) in order to modulate orthodontic movement and act on inflammation and pain. The procedures will be performed immediately after the application of forces (placement of elastic bandages) on the tooth, as described:The irradiations will be performed with the red diode laser ( = 660 nm) with 100 milliwatts output power The power of the device will be 100miliWatts and the wavelength used will be 808 nanometers (± 10nm). The optical fiber diameter of the device is 600 micrometer, therefore a spot (area) of 0.002826 centimeter2. The energy delivered per point will be 1Joule. This will require 10 seconds of application per point. As 10 points will be irradiated, the total application time will be 100 seconds and the total energy delivered will be 10Joule. The energy density will be 25 Joule / cm2 and the power density will be 35.38 Watt / cm2

Procedure: Placement of the mini-implant and verticalization

Interventions

Placement of the mini-implant and verticalization PROCEDURE

an orthodontic mini-implant will be installed in the retromandibular region. The site will be anesthetized. The region will be pre-drilled by about 5mm with a spear drill attached to an implant motor. Once the mini-implant has been selected, it will be locked into position using a kit-specific digital key. Being threaded clockwise until the intramucosal mini-implant is at the gingival level. After installation, a metallic orthodontic lingual will be glued to the molar mesial to be verticalized. The lingual button will be glued to the inclined molar mesial with orthodontic adhesive. A gray chain elastomeric ligature will attach the head of the mini-implant to the lingual button glued to the molar mesial. A light force of 150gr will be imposed (measured with a tensiometer) in all cases, regardless of tooth position. This chain elastic will be changed every 30 days for a period of 3 months. After 90 days of the experiment time, the mini-implants will be removed.

Control (placebo); Experimental:

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who agree and sign the informed consent
• healthy (ASA I - negative medical history),
• systolic blood pressure less than 140mmHg and diastolic blood pressure less than 90mmHg,
• heart rate with 70 ± 20 beats / minute
• requiring oral rehabilitation after loss of some posterior lower dental element (1st molar),
• with favorable periodontal condition to the installation of mini-implants. Any questions during the research period should be informed to the researcher so that the researcher can take the appropriate measures (the latter should provide some form of personal contact).

You may not qualify if:

• Patients who are latex allergic,
• pregnant or breastfeeding,
• smokers,
• diabetics,
• patients undergoing head and neck radiotherapy,
• coagulation disorders requiring antibiotic prophylaxis for placement of mini-implants, with absolute indication for use of local anesthetics with vasoconstrictors,
• with decompensated systemic disease,
• with systemic or local infection (periodontitis or periodontal abscess),
• who have used anti-inflammatory drugs in the last 3 months before orthodontic treatment.
• Patients who may have any complications during the research period, such as allergic reactions to any of the materials used, allergic reaction to paracetamol®,

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Anna Carolina R.T. Horliana

São Paulo, São Paulo, 11030-480, Brazil

Location

Related Publications (3)

• Fernandes MRU, Suzuki SS, Suzuki H, Martinez EF, Garcez AS. Photobiomodulation increases intrusion tooth movement and modulates IL-6, IL-8 and IL-1beta expression during orthodontically bone remodeling. J Biophotonics. 2019 Oct;12(10):e201800311. doi: 10.1002/jbio.201800311. Epub 2019 Jul 8.

  PMID: 31001928 RESULT

• Schalch TO, Palmieri M, Longo PL, Braz-Silva PH, Tortamano IP, Michel-Crosato E, Mayer MPA, Jorge WA, Bussadori SK, Pavani C, Negreiros RM, Horliana ACRT. Evaluation of photodynamic therapy in pericoronitis: Protocol of randomized, controlled, double-blind study. Medicine (Baltimore). 2019 Apr;98(17):e15312. doi: 10.1097/MD.0000000000015312.

  PMID: 31027098 RESULT

• Bauer HC, Duarte FL, Horliana AC, Tortamano IP, Perez FE, Simone JL, Jorge WA. Assessment of preemptive analgesia with ibuprofen coadministered or not with dexamethasone in third molar surgery: a randomized double-blind controlled clinical trial. Oral Maxillofac Surg. 2013 Sep;17(3):165-71. doi: 10.1007/s10006-012-0360-7. Epub 2012 Sep 5.

  PMID: 22949122 RESULT

Study Officials

• Anna carolina RT Horliana, Phd

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Only one external research collaborator, with dental training, who will be responsible for the treatments (which will open the envelopes of randomization), will know which photobiomodulation treatment will be assigned to each patient. The identification of each group will be revealed by this collaborator to all involved only after statistical analysis of the data. Therefore, the researcher responsible for data collection, and the statistician will be blinded to the treatments assigned to the groups. The patient will also be blind to the type of treatment performed since the mini-implant placement treatment will be identical in both groups and the laser treatment for photobiomodulation will be simulated in the control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, clinical professor

Model Details: 34 individuals will be randomly divided into 2 groups: G1 (control group) - verticalization by mini-implant + PBM simulation (placebo); G2 (experimental group) - verticalization by mini-implant + PBM.

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 29, 2019
• Study Start: November 15, 2020
• Primary Completion: October 30, 2021
• Study Completion: December 30, 2021
• Last Updated: June 29, 2023

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)